APPLICATION
NDA020421
TYPE
NDA
ORIGINAL APPROVAL
1995-12-21
LATEST ACTION
1997-01-14
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
FEMSTAT 3 · ReferenceDiscontinued
BUTOCONAZOLE NITRATE 2% · CREAM · VAGINAL
Approval history
1997-01-14Manufacturing (CMC) · Supplement 2 · standardAP
1996-06-06Manufacturing (CMC) · Supplement 1 · standardAP
1995-12-21Type 3 - New Dosage Form · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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